Device, system, and method for providing modular vented opening package sealing

ABSTRACT

A modular attachment is provided to attach to a packaging machine for forming a vent opening in a packaging film used for packaging an item via a packaging machine, and attaching a semipermeable or permeable vent covering material over the vent opening. The vent opening with the attached vent covering material may allow for sterilization of medical devices, medical equipment or other medical supplies while packaged within the packaging film. The modular attachment may include features for forming the vent opening in the packaging film during delivery of the packaging film for use in the packaging process, delivering the covering material to the location of the vent opening, cutting the covering material to size for covering the vent opening, and attaching the vent covering material to the packaging film so as to cover the vent opening.

TECHNICAL FIELD

Aspects of the disclosure relate generally to the field of packaging and sterilization, and in particular to devices, systems, and methods for providing one or more vented openings in a non-permeable packaging material and attaching a permeable or semi-permeable cover to the packaging material utilizing a convertible or modular attachment to a machine, so as to enable sterilization of the contents of the packaging therethrough.

BACKGROUND

It is known to provide package sealing using a form-fill-seal machine or the like (also interchangeably referred to herein as “thermoform fill and seal” or “TFFS” machines), such as the Multivac R535 Thermoforming Packaging Machine, made by Multivac, Inc., of Kansas City, Mo. Such machines may include various features, for example, as shown and described in U.S. Pat. No. 5,105,603 (“the '603 patent”). The assembly machine 1 of the'603 patent, as shown in FIG. 1 reproduced herein, may include a roller based mechanism for moving items to be sealed along a top side of an assembly machine 1. As shown in the '603 patent, items to be sealed may include, for example, packages placed in trough-shaped containers 6. The trough-shaped containers 6 are moved along the assembly machine 1 to a location where a cover film 11 is fed from a roll to cover the containers 6. The fed film 11 may seal the items, such as by use of heat, and the film may be cut after sealing, such that an encapsulated, sealed item is produced thereby. Such film may be used, for example, to seal the top of a container holding the item, or for sealing the upper half of an item that is also being sealed from beneath by another film feed.

Where packages are to be sterilized, it was known in the art to provide a package having an entire top film or entire packaging material overall that was composed entirely of a material that allows ETO, steam, or other gas passage therethrough. Drawbacks of these materials include high costs for the large top permeable or semi-permeable material quantities to provide for either an entire package made from permeable or semi-permeable material or a pre-made top film portion comprising this permeable or semi-permeable material, as well as other difficulties or complexities with manufacture.

There are some machine makers that may provide an option to make a package having this permeable or semi-permeable material in a portion of the package rather than in an entire top portion of the film. However, these machines are not convertible back to a standard TFFS machine without having this feature; thus, once the machine is made to provide this hybrid package it cannot later be used to make a non-hybrid package. Moreover, such machines can only be made to prepare one size of packaging; thus, the machine is pre-ordered and made to accommodate that one size of packaging without it being possible to later change those sizes. Finally, the machines on the market can only make at most two packages per machine index or cycle.

There is a need, however, for devices, systems, and methods for providing one or more openings, such as vent openings, in such films, along with the addition of a covering feature for such vents that allows vent communication with the contents of such packages, such as for use in sterilization, without requiring such large amounts of film to encapsulate the packaged product, while allowing for interchangeability of the machine to provide packages with such vent openings (also known as hybrid packages) or to provide packages without vent openings (also known as non-hybrid packages).

SUMMARY

A device, system, and method for packaging that includes providing a modular attachment to standard TFFS machines to make a vent opening and a vent covering in a sealing or other packaging film (e.g., a polymer film) is disclosed herein. Such packaging may encapsulate an item by using a packaging machine, such as a TFFS machine, to seal the item in a package, and may further include attaching a semipermeable or permeable vent covering material to the packaging film via a convertible or modular attachment system that provides a vent passageway. For example, the packaging film may be used to sealably protect an item that may be sterilized, such as a medical or surgical instrument, device or product, including but not limited to, a surgical drape, surgical gown, medical suction tubing, medical suction handle, laryngeal mask airway (LMA), catheter, syringe, gloves, wound care dressing products, and/or other medical related clothing, equipment, and medical instruments, including instruments contained in a container, such as may comprise or be used in a medical kit, and the like. The semipermeable or permeable vent covering material may be used to allow sterilization of the item contained within the packaging film by allowing sterilization gases to pass therethrough. Such sterilization gases may include use of ethylene oxide (ETO), for example, or steam sterilization. The device, method, and system may include a modular attachment having features for forming a vent opening in the packaging film during delivery of the packaging film for use in the packaging process, delivering the vent covering material to the location of the vent opening, cutting the vent covering material to size for adequately covering the vent opening, and attaching the vent covering material to the packaging film so as to cover the vent opening. The joining of the vent covering material to the packaging film may include a heat sealing process or other conventional technique used in the art. This is advantageous because the entire film of the outer package does not need to be made from a semipermeable or permeable film, thus saving on cost and production complexities with using such film, and instead the final package can comprise at least one such vent opening sealed with a semipermeable or permeable vent covering material. This saves on the cost of film as well as allowing for ease of manufacture by attaching a modular attachment to the desired machines.

Aspects of the present disclosure further relate to a modular attachment to a machine for automated packaging of an item, such as a medical instrument, device, or product that may need to be sterilized, the attachment may include features for providing an opening in the packaging and a vent covering material for covering the opening in the packaging. The machine may include a conveyor for conveying the item in an assembly line fashion, such as to a location where a packaging material may cover at least a portion of the item. The packaging material may be delivered via a roller assembly and/or other features that deliver the film to the location where the item is covered. Any method commonly used in the art for delivering of packaging material may also be used.

The modular attachment may further include an automated puncturing device and/or other features for puncturing or otherwise creating or forming a vent opening in the packaging material as part of the assembly process. The features for puncturing or otherwise creating such opening may be located so as to integrate in an automated fashion with the automated packaging of the item, such as by integrating a convertible or modular attachment to a TFFS machine that can provide such puncturing feature. The vent opening may be circularly or ovally shaped, or may have a rectangular or square shape, for example, or any other shape that is appropriate for providing a vent.

Aspects further include automated delivery, cutting to size, and emplacement of a vent covering material for covering the vent opening. Delivery of the vent covering material may include, for example, use of a vent material roller assembly for delivering the vent covering material to the vent opening in the packaging material. Such roller assembly may be located so as to integrate in an automated fashion with the automated packaging of the item, such as by integrating a convertible or modular attachment to a TFFS machine that can provide a roller assembly.

Cutting to size of the vent material may include, for example, use of a cutting device for cutting the vent covering material prior to delivery for covering the opening in the packaging material. Such cutting device may be located so as to integrate in an automated fashion with the automated packaging of the item, such as by integrating a convertible or modular attachment to a TFFS machine that can provide a cutting device.

Emplacement of the vent material may include, for example, devices and/or mechanisms for positioning and holding the vent covering material at the vent opening location, and heating and/or use of an adhesive, and/or other features for attaching the vent covering material to the packaging film. Such emplacement mechanisms may be located so as to integrate in an automated fashion with the automated packaging of the item, such as by integrating a convertible or modular attachment to a TFFS machine that can provide an emplacement mechanism.

Another advantage of the modular attachment added to a machine as disclosed herein is the convenience of being able to switch back and forth between a machine that makes standard packages, e.g., packages without the vented opening and cover and without the modular attachment (e.g., non-hybrid packages), and a machine that contains the modular attachment and can make vented packages (e.g., hybrid packages). The modular or convertible attachment can be easily added to or removed from a standard packaging machine depending on the type of packages that are desired. For example, where a vented package is desired, the modular attachment can be connected to the packaging machine being used to make the standard packages. Once the vented packages are completed and it is desired to convert back to the standard packages, the modular attachment can be easily removed, or alternatively bypassed, to allow for continued operation of the packaging machine to form the standard packages. Adding the modular attachment to an existing packaging machine allows for a low cost option to modify the existing equipment and machine to allow for a modification to the type of packages that are produced without permanently changing the packaging machine.

Yet another advantage of the modular attachment is that any number of vent openings and covers can be placed on multiple packages. For example, one or more packages or at least the top film of one or more packages can be fed through the attachment to create a vent opening and to seal it with the vent covering material. In yet another embodiment, a single package can be made with one or more vent openings in the package, depending on how many entry points are desired to the interior of the package for the sterilization gases. Moreover, the modular attachment can be used on any size packaging, such that different size packages can be made on the same machine and do not require use of a different modular attachment but merely an adjustment of the components on the existing modular attachment.

Additional advantages and novel features of these aspects will be set forth in part in the description that follows, and in part will become more apparent to those skilled in the art upon examination of the following or upon learning by practice of the disclosure.

BRIEF DESCRIPTION OF THE DRAWINGS

The accompanying drawings, which are incorporated into and constitute a part of this specification, illustrate one or more example aspects of the present disclosure and, together with the detailed description, serve to explain their principles and implementations.

FIG. 1 shows a packaging machine of the prior art.

FIG. 2 shows an example packaging machine with a modular attachment for providing an opening and a vent, in accordance with aspects of the present disclosure.

FIG. 3 shows a perspective view of an example convertible or modular machine attachment comprising a vent opening and covering station, in accordance with aspects of the present disclosure.

FIG. 3A shows a cross-sectional view of the example vent opening and covering station 250 a of FIG. 3, including details of various additional features in accordance with aspects of the present disclosure.

FIG. 4 shows an example modular vent opening and covering station from a perspective view on one side of a packaging film being drawn therethrough, in accordance with aspects of the present disclosure.

FIG. 5 shows a side view of a portion of the modular vent opening and covering station of FIG. 4.

FIG. 6 shows a perspective view of the modular vent opening and covering station of FIG. 4 from the reverse side angle from the view shown in FIG. 4.

FIG. 7 shows a close up view of the packaging film for the modular vent opening and covering station of FIG. 4 moving past an element of an example puncturing device for forming vent openings, just after a vent opening has been formed in the packaging film.

FIG. 8 shows a close up view of the device for attaching a vent covering material to a packaging film using the modular vent opening and covering station of FIG. 4.

FIG. 9 shows a perspective view of the modular vent opening and covering station of FIG. 4 from the same side of the packaging film as shown in FIG. 4.

FIGS. 10 and 11 show partially disassembled views of elements of an example cutter, as well as other components, in accordance with aspects of the present disclosure.

FIG. 12 shows a partially disassembled view showing the roll for the packaging material and an element of the cutter, as well as other components, in accordance with aspects of the present disclosure.

FIG. 13 shows a partially disassembled side view showing various portions of the feeder, the packaging material, and other components, in accordance with aspects of the present disclosure.

FIG. 14 shows a perspective view of another example modular vent opening and covering station, in accordance with aspects of the present disclosure.

FIG. 15 shows a side view of an example packaging machine having a modular vent opening and covering station, along with a schematic indication of the sequence of various functions for vent opening and covering related operation, in accordance with aspects of the present disclosure.

FIG. 16 shows the schematic portion of FIG. 15, including details on the sequence of various vent opening and covering related operations thereof.

FIGS. 17 and 18 show additional representative schematic views of operation in accordance with example implementations of a packaging machine having a modular vent opening and covering station in accordance with aspects of the present disclosure.

FIG. 19 shows additional representative views of various features in accordance with a packaging machine having a modular vent opening and covering station in accordance with aspects of the present disclosure.

FIG. 20 shows an example packaged product produced using a modular packaging attachment in accordance with aspects of the present disclosure, the package is shown with the top film being opened.

DETAILED DESCRIPTION

The detailed description set forth below in connection with the appended drawings is intended as a description of various configurations and is not intended to represent the only configurations in which the concepts described herein may be practiced. The detailed description includes specific details for the purpose of providing a thorough understanding of various concepts. However, it will be apparent to those skilled in the art that these concepts may be practiced without these specific details. In some instances, well known structures and components are shown in block diagram form in order to avoid obscuring such concepts.

Aspects of the present disclosure relate to devices, systems, and methods for providing a vent opening and a semipermeable or permeable vent covering material in a sealing or other packaging film (e.g., a polymer film) for packaging at least a portion of an item, such as by using a packaging machine, such as a thermoform fill and seal (TFFS) machine, in combination with a convertible or modular attachment comprising a vent opening and vent covering material station, or alternatively, having the vent opening/covering station built into the machine. For example, the packaging film may be used to sealably protect an item that may be sterilized, such as a drape, gloves, gown, or other medical related clothing or equipment, or a medical instrument, which may be contained in a container, film package, or such as may comprise or be used in a medical kit. A semipermeable or permeable vent covering material can be placed on a top film layer or cover having an opening or puncture, to enclose the container, package or kit that may be used to allow sterilization of the item contained within the packaging film by allowing sterilization gases to pass therethrough while preventing other gases or contaminants from entering the package through the vent covering, maintaining the interior of the package in a sterilized and relatively contaminant free state. Such sterilization gases may include use of ethylene oxide gases (ETO), for example. In one embodiment, a modular attachment can be placed on or attached to a packaging machine and may include features for forming the vent opening in the packaging film during delivery of the packaging film for use in the packaging process, delivering the vent covering material to the location of the vent opening, cutting the vent covering material to size for covering the vent opening, and attaching the vent covering material to the packaging film so as to cover the vent opening. These steps may be performed on a standard TFFS machine, for example, via coupling of the convertible or modular attachment to the standard TFFS machine, or alternatively, via the integration of the vent opening/covering station into the TFFS machine such that it is not modular.

FIG. 2 shows an exemplary embodiment of a packaging machine including a modular attachment for providing an opening and a vent, in accordance with aspects of the present disclosure. The packaging machine 200 of FIG. 2 can include a machine frame 202 and supply roll 203 for supplying a bottom film for covering a lower portion of a product with film. The machine 200 can include a product delivery belt and/or other transport features 210 for moving products to be packaged, for example in a machine direction from the first end 202 a of the frame 202 toward the second end 202 b. A top film may be supplied from a supply roll 220 to cover an upper portion of the product with film and/or to seal the product within a package. Sealing of the film about the product can be done by conventional techniques known as part of the standard TFFS machine features. For example, in one standard embodiment a top web of film and a formed bottom web of film can be drawn together to a seal station where heat sealing can be performed. The machine 200 can further include a vent opening and covering station 250, which is part of a convertible or modular attachment for coupling to the machine 200, that may include various features for punching or cutting a vent opening in the film delivered from the top film supply roll 220, delivering vent covering material, cutting the vent covering material to an appropriate size to cover the vent opening, and attaching the vent covering material to the top film so as to cover the vent opening. In one aspect, a vent covering material can be provided from a material consisting of Tyvek® at different grammage, such as 1073, 1059, 2FS, a paper material, either re-inforced or not re-inforced, and the like. In another aspect, a vent covering material can be provided from a material such as Tyvek® made by DuPont® of Wilmington, Del.

FIG. 3 shows a perspective view of an example convertible or modular attachment comprising a vent opening and covering station 250 a. As shown in FIG. 3, the vent opening and covering station 250 a may include a single covering roll 300, which may be used to supply a vent covering material for covering a vent opening in a top film (e.g., top film from supply roll 220 of FIG. 2). The station 250 a may further include a puncturing device 310, such as a punch or cutter, to create the vent opening in the top film. The top film (e.g., from supply roll 220 of FIG. 2) may be fed into the station 250 a at or near location F1 and past location F2. A vent opening may be formed, for example, in the top film during the feed of the top film past the puncturing device 310. Vent openings may be punched at intervals in the film feed, such that the vent opening can then be located above a top surface of items being sequentially covered by the top film, for example, as the top film is emplaced on the item being covered as it passes along the product delivery belt and/or other transport features (see belt and/or other transport features 210 of FIG. 2).

The top film with the vent opening may pass location F2 after puncturing by puncturing device 310. As the vent opening passes location F2, a portion of the vent covering material 301 fed from roll 300 may align with the vent opening. A cutter may cut the vent covering material 301 to size so as to cover the vent opening, and the cut portion of the vent covering material 301 may be emplaced and attached to the top film so as to cover the vent opening. The covering material 301 may be attached to the top film, for example, via various attachment features as known in the art, which may include, for example, use of a heated press 320, with or without use of an adhesive, or other appropriate features and/or procedures to ensure the covering material 301 is sealably attached to the top film about the vent opening.

FIG. 3A shows a cross-sectional view of the modular vent opening and covering station or attachment 250 a of FIG. 3. In addition to the features shown in FIG. 3, FIG. 3A further shows an additional portion of the puncturing device 315, elements of a feeder 350, a cutter 360, and various features 380 for electrical or other operational control of the heated press, the feeder, and the cutter. For example, such features 380 may include one or more solenoids, electric motors, and electronic or other automated or other control features to control such operations.

FIGS. 4-13 contain pictures of various views of other exemplary embodiments of a modular vent opening and covering station or attachment 250 b and portions thereof, as well as portions of an overall packaging device in which the vent opening and covering station 250 b operates, in accordance with aspects of the present disclosure. The vent opening and covering station 250 b of FIGS. 4-13 may be, or may be similar to, the vent opening and covering station 250 shown in FIG. 2 or the station 250 a shown in FIG. 3, for example. As shown in FIGS. 4-13, operations of the vent opening and covering station or attachment 250 b may include receiving a top film 221 (e.g., received from a top film roll, such as or similar to the roll 220 of FIG. 2), which passes locations F1′ and F2′; the top film 221 may thereby be engaged with a puncturing device 310′, 315′ and various features for cutting, positioning, and attachment of the covering material to the top film 221.

FIG. 4 shows the vent opening and covering station 250 b from a perspective view where one side of a film 221 can be drawn therethrough. In operation for creating a vent opening in the top film 211, for example, the top film 221 may be drawn past the element of the puncturing device 310′ to the point shown in FIG. 4, and movement of the top film 221 may then be momentarily stopped. The puncturing element 310′ may then operate a punch feature so as to cause an outer shaped punch to be expelled from the puncturing element 310′ so as to cut a vent opening, for example, in conjunction with cooperative operation of a second element 315′ (FIGS. 6 and 10-12), which may include, for example, a punch receiving opening and a source of suction, thereby enabling a clean cut of the vent opening in the top film 221 and can draw the cut portion away by suction therefrom. FIG. 5 shows a side view of a portion of the vent opening and covering station 250 b. FIG. 6 shows a perspective view from the reverse side of the film 221 from the view shown in FIG. 4.

FIG. 7 shows a close up view of the film 221 moving past an element 310′ of a puncturing device for forming vent openings, just after a vent opening 601 has been formed. FIG. 7 is from a perspective view from the reverse side of the film 221 from the view shown in FIG. 4. The image of FIG. 7 shows a close up view of the film 221 moving past an element of the puncturing device 310′ for forming vent openings, just after a vent opening 601 has been formed in the top film 221.

FIG. 8 shows a close up view of a portion 320 of the device for attaching the vent covering material to the top film 221. After the vent opening has been formed in the top film 221, the portion of the top film 221 having the vent opening therein may be moved to a position adjacent or near the device 320 for attaching the vent covering material to the top film 221. The top film 221 may be stopped, such that the vent opening remains adjacent to or near the device 320. A portion of the vent covering material may also be drawn from the vent covering material roll 300′ (FIGS. 5 and 6) so as to be adjacent to the vent opening in the top film 221 and adjacent or near the device 320 when the film 221 is at the stopped point. A properly sized portion of the vent covering material from roll 300′ may then be cut to a size so as to cover the vent opening and held in place thereby (e.g., by pressure between a portion of the device 320 and the film 221). The device 320 may then be used to attach the cut cover portion to the top film 221 portion about the vent opening. For example, the cut cover film portion 221 may be sandwichably compressed to the top film 221 between two portions of the device 320, and the device 320 may then heatably seal the cover film portion to the top film 221, where device 320 can be a support plate that allows heat sealing to take place, as shown in FIG. 3A. For the vent covering material, it typically can be cut to a size that is just larger than the vent opening. For example, in one aspect, a seal width of about 6 mm can be assumed such that at least an additional 6 mm is allowed for sealing width and at least an additional 2 mm can be added for all edges. For example, where the vent opening is 30 mm×40 mm, the vent covering material can be cut to at least 46 mm×56 mm, however, any dimensions are possible. Any dimension vent opening can be used as well as any size vent covering material that adequately covers and seals the vent opening.

FIG. 9 shows a perspective view of the vent opening and covering station 250 b from the same side of the film 221 as shown in FIG. 4, and also shows the film 221 being drawn along the product delivery belt and/or other transport features of the packaging machine. The view of FIG. 9 shows a vent opening covered by a cover film portion 901 that is sealably attached to the film 221.

FIGS. 10 and 11 present partially disassembled views of elements of the cutter 310′, and the suction chute 315′, as well as other components, in accordance with aspects of the present disclosure. The vent dimension can be changed, in one embodiment, by changing the cutter tooling. The suction chute 315′ can be used to vacuum and direct and/or remove the cut pieces from the punch holes section to a waste collector or a trash bin.

FIG. 12 is a partially disassembled view showing the roll 300′ for the covering material 301′ and the elements of the cutter 301′ and suction chute 315′, and the corresponding heat sealer assembly 316′ for the covering material, as well as other components.

FIG. 13 is another partially disassembled side view showing various portions of the feeder 350′, the covering material 301′, the heated press 320′ and other components, in accordance with aspects of the present disclosure.

FIG. 14 shows a perspective view of another embodiment of a modular and moveable attachment comprising a vent opening and covering station 1250, in accordance with aspects of the present disclosure. The station 1250 of FIG. 14 is similar to that shown in FIG. 3, but includes three sets of vent opening and covering components, along with three corresponding covering rolls 1300, which may be used to supply covering material for covering three vent openings in a top film (e.g., top film from supply roll 220 of FIG. 2); more or less covering rolls can be used. The station 1250 may include three puncturing devices 1310 to create three vent openings in the top film; again more or less puncturing devices and covering rolls may be used, however, it is preferred that the same number of covering rolls as puncturing devices or puncturing mechanisms be used. In accordance with aspects of the present disclosure, the top film (e.g., from supply roll 220 of FIG. 2) may be fed into the station 1250 through location F5 and past location F6. The vent openings may be formed, for example, in the top film during the feed of the top film past the puncturing devices 1310. The vent openings may be punched at intervals such that the vent openings will then be located above the top surfaces of items being covered by the top film. For example, the top film with three vent openings may be cut into multiple film strips, which may then each be emplaced on items being covered as these items pass along a product delivery belt and/or other transport features for a packaging machine (see belt and/or other transport features 210 of FIG. 2, which may include, for example, three spaced rows of devices).

The top film with the vent openings may pass location F6 after being punctured by puncturing devices 1310, as shown in FIG. 14. As the vent openings pass near location F6, a portion of the covering material 1301 fed from each of rolls 1300 may align with corresponding vent openings in the film. A cutter may cut corresponding portions of covering material 1301 to size such that it may cover the corresponding vent openings in the top film, and the cut portions of the covering material 1301 may be attached to the top film so as to cover each vent opening. The vent covering may be sized similarly to the vent opening or it may be larger than the vent opening; however, the vent covering is at least large enough to cover the vent opening. Each portion of the covering material 1301 may be attached to the top film, for example, via various attachment features (also interchangeably referred to herein as an “attachment assembly”), which may include, for example, use of a heated press 1320 and/or positioning and/or other mechanisms; the attachment process may also or alternatively include use of an adhesive, or other appropriate features and/or procedures to ensure the covering material 1301 is sealably attached to the top film.

FIG. 15 shows a side view of yet another embodiment of a packaging machine 2200 having a modular vent opening and covering station or attachment 2250, along with a schematic indication of the sequence of various functions for vent opening and covering related operation, in accordance with aspects of the present disclosure. The packaging machine 2200 of FIG. 15 may be similar to the machine 200 of FIG. 2, including having a machine frame 2202 and supply roll 2203 for supplying a bottom film for covering with film a lower portion of a product to be packaged. The machine 2200 may include a product delivery belt and/or other transport features 2210 for moving products to be packaged, for example in a direction from a first end 2202 a of the frame 2202 toward a second end 2202 b. A top film may be supplied from a supply roll to cover with film an upper portion of the product to be packaged. The machine 2200 may further include a modular and moveable attachment comprising a vent opening and covering station 2250 that may include various features for punching or cutting a vent opening in film delivered from the top film supply roll, delivering, cutting, and positioning a vent covering material, and attaching the cut and positioned vent covering material to the top film to cover the vent opening.

The schematic portion of FIG. 15, appearing at the lower portion of the figure as shown, indicates the sequence of various vent opening and covering related operations, which are further shown and detailed in FIG. 16. As shown in the representative schematic of FIG. 16, in a first sequence for operating the machine (e.g., packaging machine 2200 of FIG. 15), the bottom film, the top film, and the vent covering material may all be loaded to the packaging machine. The top film may be fed through the modular vent opening and covering station (e.g. station 2250 of FIG. 15), and the covering material may also be fed within the modular vent opening and covering station. The top film may pass through the features for vent formation, such as through a punching device, for example. These operations may occur via any known method in the art, such as, for example, via servo driven feed and cutting.

Next, as further shown in FIG. 16, the vent covering material may be fed, positioned, cut, and then attached to the top film, such as by heat sealing (e.g., at a heat sealing station). The top film with the attached vent covering material may then be delivered for further operations of the packaging machine, along the lines as normally provided by a packaging machine in the absence of the vent opening and covering related operation. These further packaging related features may include, for example, sealing the packages with the contained item, providing ink jet or other printing on the packaging, and cutting and/or slitting the cover film for the packages to provide separated, individually covered and sealed packages, with various features as needed for use thereof. In the embodiment shown in FIGS. 15 and 16, Step 1 shows an un-winder for loading the top and bottom forming web (e.g., roll of forming film). The top web roll can be loaded and threaded through the modular attachment. The bottom web roll can be loaded using a normal loading process that is typically used for TFFS machines; it is not required to thread the bottom film through the attachment. Next, the packages can be formed and preheated at Step 2. At this step, the top web passes through the attachment for hole punching the vent holes and is then followed by a heat-sealing step to attach the vent material. In the embodiment shown, the holes that are punched are in a series of 4 punches, but any size and number can be used that fits the width of the packaging machine. At Step 8, the roll of vent material can be loaded and threaded through the attachment; the vent material in this embodiment can be a Tyvek or paper material.

Then the desired items to be packaged can be loaded into the formed packages, whether manually or automatically, depending on the machine capabilities, as shown at Step 3. At Step 4, a sealing step is shown where the vented web is advanced in the machine direction D to the heat sealing station at Step 4, where sealing can occur as in a conventional TFFS machine. Step 5 illustrates ink jet printing, which is a conventional process, and at Step 6, a cross-cutting of the packages occurs to separate the connecting rows of packages into separated strips, which is also conventionally known. Finally, at Step 7, the slitting step occurs to separate or singulate the strips of packages into individual packages.

It is not necessary to follow the numeric order of these steps in practice; for example, step 8 would not occur as the last step in the process but would rather occur early on in the process so that the vent material is pre-loaded and ready for use when the packages are being made. In one instance, the length of the machine can be designated as L, which can vary depending upon the machine steps present in the TFFS machine. In another instance, the machine length L can be tailored to product requirements, and for example can be a length greater than 8000 mm. FIG. 15 demonstrates one embodiment of a finished, packaged product 2260 where four packages per machine cycle were made within a mold area of approximately 500 mm×500 mm.

FIGS. 17 and 18 show additional representative schematic views of operation in accordance with example implementations of a packaging machine having a modular vent opening and covering station, in accordance with aspects of the present disclosure. In the example implementation as shown in FIGS. 17 and 18, one or more diverters 3306 can be provided to direct the web/film to the desired path and a dancer 3300, which can function as a web/film accumulator, may be used to facilitate operation. A servo-feed 3301 can also be provided, to provide unwinding of the web/film, which can be motorized. In addition, a paper de-winder 3305 may be included, and in the embodiment shown in FIGS. 17 and 18, since it is a 2× line, there can be two de-winders. A paper cutting station 3303 can be situated adjacent the paper de-winder 3305. A sealing station 3304 is provided. After the web/film passes the cutting station 3303, the punched holes 3307 in the film are shown. FIGS. 17 and 18 further describes the detailed area shown in FIG. 16.

FIG. 19 shows additional representative views of various features in accordance with a packaging machine having a modular vent opening and covering station in accordance with aspects of the present disclosure. As shown in FIG. 19, in representative diagram portion 1500 a, the attachment process for attaching the vent cover film to the top film may include, for example, air pressure based use of one or more press components 1510, such as air pressure driven pistons in cylinders, to compress the vent covering material 1515 and top film 1520 between a cold mold or molds 1525 and a hot seal mold or molds 1530, as shown at Step 4, in accordance with aspects of the present disclosure. The top press and the bottom press can both be compressed using air pressure. The top film 1520 can comprise an HDPE film, for example. In addition, the top film 1520 can comprise an HDPE material, for example, with holes. The top cold mold, for example, can be transferred by an X-Y-Z arm (i.e., 3 servo-axis). The cold mold 1525 may, for example, be water cooled. In certain aspects, the seal can be a circular seal or a square seal, and in another aspect, the seal can have a width of about 6 mm.

Representative diagram portion 1500 b of FIG. 19 shows a representative top view of the cold mold portions 1525 having features for holding and positioning of the vent cover material, in accordance with aspects of the present disclosure. These holding and positioning features may be suction based, for example, and may include one or more vacuum operated suction/silicon pads to pick and transfer the paper or Tyvek to the sealing station. The top mold can be operated by, for example at Step 3, a 3-axis arm and vacuum.

Representative diagram portion 1500 c of FIG. 19 shows a representative top view of an example insertion portion 1535 and receiving portion 1540 for a cutting device used to form vent openings in a top film, such as by a punch operation of the insertion portion 1535 into the receiving portion 1540, in accordance with aspects of the present disclosure. For example, at Step 2 of 1500 c cutting into 4 pieces is illustrated and then applying auto-pitch (i.e., y-axis pitching).

Representative diagram portion 1500 d of FIG. 19 shows a representative top view of the example insertion portion 1535 and auto-pitch portion 1540 of diagram portion 1500 c in an engaged position for cutting, such as via servo operation. In the example shown, there can be vacuum blocks along the bottom and x-pitching to mechanically adjust. The vacuum blocks can operate to hold the Tyvek in position before cutting. In the embodiment shown at Step 1, the servo-feed can have a 2× length of the vent material.

Representative diagram portion 1500 e of FIG. 19 shows a representative cross-sectional view of another aspect of a cutting feature and cover feed for a two vent opening and cover device, in accordance with aspects of the present disclosure. Illustrated at 1500 e are two servo-feed nip rollers 1708 that can be driven by, for example, a servo-motor, and can feed or pull the vent material 1700, for example Tyvek or paper or the like, toward the cutters 1702, 1704, where the servo-feed nip rollers. Two vent coverings can be stamped out of the vent material using two cutters, 1702 and 1704, such as shear cutters, for example. Each cutter can have a top vertical bar and a bottom vertical bar that comes together toward the film to cut a vent covering out of the vent material. The cutters 1702 and 1704 can be slightly off-set from one another, this off-set feature aids in providing the desired cutting action. The cutters 1702 and 1704 can be activated by cylinder or by servomotor. After the vent material 1700 is fed through the machine, the cutters 1702 and 1704 can be activated. The cutting action can result in two pieces of vent material covering (not shown) of approximately equal length. In this embodiment, a square or rectangular vent covering can be provided. If a more circular vent covering cutout is desired a different cutter mechanism can be provided, such as a punch cutter. In addition, two vacuum blocks 1706 can be provided to hold or retain the cutout vent covering for the next process step, which is the heat sealing step. In referring to the previous figures in FIG. 19, at 1535, for example, the first two vents can be stationary where the next two vents are moveable by Y-pitching.

FIG. 20 show an example packaged product produced using a packaging device in accordance with aspects of the present disclosure. As shown in FIG. 20, the packaged product 1600 may include a film 1610 for containing the product 1615 and a semipermeable or permeable vent cover portion 1620 attached to the top film 1610 to cover the vent opening. The film 1610 may comprise, for example, a polymer film, such as high density polyethylene (HDPE) with a peelable layer, PolyEthylene Terephthalate (PET) laminate with a peelable layer, linear tear opening film for non-peelable pouches, and the like. The semipermeable or permeable vent cover portion 1620 may comprise a film that will allow ETO or steam sterilization, such as, for example, Tyvek® or paper material. Any size packages can be provided with the vent feature as described herein. The sample package shown in FIG. 20 is in the process of being opened where the top lid including vent covering is in the process of being peeled off of the package.

In addition, there is no limit to the number of packages across that can be made, with the exception of being limited by the width of the machine. Moreover, the vent location, i.e., where in the package it is placed, and the dimension can be changed and modified as the user wishes by simply making changes to the modular unit settings. For example, packages of different dimensions can be made using the modular attachment by moving the punch and seal mechanism up and down accordingly. In FIG. 3A, an embodiment is shown where the distance between the punch and the seal station is exactly the length of a package. In order to accommodate packages of different lengths, in one aspect, one can move just the punch/seal station up or down accordingly to the desired size. In another example, the dimensions of packages can be adjusted by moving the entire attachment, which can be on a rail, and can be moved back and forth accordingly. In an example shown in FIG. 2A, the attachment distance to the TFFS seal station is a round multiple number length of the package length, thus, this can be adjusted accordingly in conjunction to the adjustment made to the punch/seal station. In contrast, where the station is not a round multiple number of length of packages, then the hole design may be in a location that is in the middle of the pouch, thus, the location of the hole with respect to the pouch may be shifted or uncontrollable in position.

A regular package without the vent described herein can easily be made from a TFFS machine having the modular attachment in place by either removing the attachment fully or, alternatively, one can by-pass the attachment and use the remaining stations of the machine to produce packages without the vented feature described herein. This easy conversion to/from hybrid packages saves on time and cost when different types of packages are required or even different sizes, as sizes can also easily be interchanged as discussed above.

While the aspects described herein have been described in conjunction with the example aspects outlined above, various alternatives, modifications, variations, improvements, and/or substantial equivalents, whether known or that are or may be presently unforeseen, may become apparent to those having at least ordinary skill in the art. Accordingly, the example aspects, as set forth above, are intended to be illustrative, not limiting. Various changes may be made without departing from the spirit and scope of the disclosure. Therefore, the disclosure is intended to embrace all known or later-developed alternatives, modifications, variations, improvements, and/or substantial equivalents.

Thus, the claims are not intended to be limited to the aspects shown herein, but are to be accorded the full scope consistent with the language of the claims, wherein reference to an element in the singular is not intended to mean “one and only one” unless specifically so stated, but rather “one or more.” All structural and functional equivalents to the elements of the various aspects described throughout this disclosure that are known or later come to be known to those of ordinary skill in the art are expressly incorporated herein by reference and are intended to be encompassed by the claims. Moreover, nothing disclosed herein is intended to be dedicated to the public regardless of whether such disclosure is explicitly recited in the claims. No claim element is to be construed as a means plus function unless the element is expressly recited using the phrase “means for.”

It is understood that the specific order or hierarchy of the processes/flowcharts disclosed is an illustration of example approaches. Based upon design preferences, it is understood that the specific order or hierarchy in the processes/flowcharts may be rearranged. Further, some features/steps may be combined or omitted. The accompanying method claims present elements of the various features/steps in a sample order, and are not meant to be limited to the specific order or hierarchy presented.

Further, the word “example” is used herein to mean “serving as an example, instance, or illustration.” Any aspect described herein as “example” is not necessarily to be construed as preferred or advantageous over other aspects. Unless specifically stated otherwise, the term “some” refers to one or more. Combinations such as “at least one of A, B, or C,” “at least one of A, B, and C,” and “A, B, C, or any combination thereof” include any combination of A, B, and/or C, and may include multiples of A, multiples of B, or multiples of C. Specifically, combinations such as “at least one of A, B, or C,” “at least one of A, B, and C,” and “A, B, C, or any combination thereof” may be A only, B only, C only, A and B, A and C, B and C, or A and B and C, where any such combinations may contain one or more member or members of A, B, or C. Nothing disclosed herein is intended to be dedicated to the public regardless of whether such disclosure is explicitly recited in the claims. 

1. A machine for packaging an item, the machine comprising: a conveyor for conveying the item; a packaging film for covering at least a portion of the item; a packaging film roller assembly for delivering the packaging film to the item; the machine further comprising a convertible attachment, the attachment comprising: a puncturing device for puncturing a vent opening in the packaging film; a vent covering material for covering the vent opening; and a vent covering material roller assembly for delivering the vent covering material to the opening in the packaging film.
 2. The machine of claim 1, wherein the packaging film is non-permeable.
 3. The machine of claim 1, wherein the packaging film is received from a packaging film roll.
 4. The machine of claim 1, wherein the vent covering material is permeable.
 5. The machine of claim 4, wherein the vent covering material is permeable to a sterilization substance.
 6. The machine of claim 5, wherein the sterilization substance is ethylene oxide (ETO).
 7. The machine of claim 1, wherein the vent covering material is received from a vent covering material roll.
 8. The machine of claim 1, further comprising: a second packaging film for covering at least a second portion of the item.
 9. The machine of claim 1, wherein the vent covering material roller assembly is attachable to the packaging film roller assembly.
 10. The machine of claim 9, wherein the packaging film roller assembly includes a frame, and wherein the vent covering material roller assembly is attachable to the packaging film roller assembly via the frame.
 11. The machine of claim 1, wherein the puncturing device is attachable to the packaging film roller assembly.
 12. The machine of claim 11, wherein the packaging film roller assembly includes a frame, and wherein the puncturing device is attachable to the packaging film roller assembly via the frame.
 13. The machine of claim 1, further comprising: an attaching assembly for attaching the vent covering material to the packaging film.
 14. The machine of claim 13, wherein the attaching assembly includes: a heat sealing device operable to heat sealably attach the vent covering material to the packaging film.
 15. The machine of claim 13, further comprising: a vent covering material cutter for cutting the vent material.
 16. The machine of claim 13, further comprising: a vent covering material positioner for positioning the vent material.
 17. A modular attachment for use with a packaging machine for packaging an item, the packaging machine having a conveyor, a packaging film roller assembly for delivering a packaging film for packaging the item, the modular attachment comprising: a puncturing device operable to puncture a vent opening in the packaging film; a vent covering material for covering the vent opening; and a vent covering material roller assembly for delivering the vent covering material to the vent opening.
 18. The modular attachment of claim 17, further comprising a vent material cutter for cutting the vent covering material.
 19. The modular attachment of claim 17, further comprising an attachment assembly for attaching the vent covering material to the packaging film.
 20. The modular attachment of claim 17, further comprising a frame, wherein the puncturing device and the vent covering material roller assembly are attached to the frame. 